Field of the Invention
The invention generally relates to the field of orthopedic surgery and concerns a method of fastening a soft tissue graft in an opening provided in a human or animal bone, wherein the soft tissue graft comprises an end portion to which a suture is attached or which is suitable for such attachment.
Description of Related Art
The term “soft tissue graft” or just “graft” as used in the present text is in particular an autograft, allograft or xenograft, but it may also be an original soft tissue to be re-attached to a bone from which it has been detached by injury or surgery. The soft tissue graft is in particular a tendon or ligament graft or an original tendon or ligament. However, the term “soft tissue graft” or “graft” is meant to encompass also prosthetic elements replacing or complementing soft tissue, i.e. in particular artificial tendon or ligament tissue or tendon or ligament substitutes or partial substitutes that are to replace or strengthen a ruptured or otherwise defective tendon or ligament and, for such purpose, are to be fastened in a bone opening. It could also encompass the extension of a meniscus graft or textile ribbons which are known as alternatives to cerclage wires, wires, or plate/screw systems, for example for fixing bone fragments, or for stabilizing fractures or osteotomies.
The term “bone” as used in the present text is a piece of a viable bone tissue, which may be complemented with artificial bone replacement material.
The term “suture” as used in the present text is a suture as used in surgery but may also be another suitably flexible lengthy fixation element such as, for example, a ribbon, cable or wire.
At least one end portion of the soft tissue graft has at least one suture attached thereto or is suitable for such attachment. This means that the suture is attached to the soft tissue graft either by a manufacturer or by the operating team, wherein in the latter case such attachment is carried out either ex situ (in the operating room) or in situ (in the operation site). In addition to its function according to the invention, which will be detailed below, the suture will usually have further per se known functions such as, for example, re-enforcing the soft tissue graft, combining a plurality of graft strands, adapting a cross section of an end portion of the graft to a cross section of the bone opening or a fastener, in situ positioning and/or tensioning the graft and so on. The attachment of the suture to the soft tissue graft may, for example, be achieved by stitching (in particular per se known stitched graft ends) or by threading the suture through a folded end of the graft or through an eyelet-like feature provided on the end of the graft. If the soft tissue graft itself is suture-like, i.e., is a suitably flexible fine ribbon or cable, the graft itself may serve as the named suture being attached to the graft in the widest sense of the term “attached”.
The opening provided in the bone for the fastening according to the invention is in a per se known manner a tunnel leading through the bone or a blind opening extending into the bone from a bone surface and comprising a closed end within the bone. This opening is preferably provided by drilling but can also be provided by, for example, punching (ultrasonic punching), i.e. this opening will often have a circular or non-circular cross section remaining the same over most of the depth of the opening, but this is not a condition for the invention. The opening may also have a plurality of sections with differing cross sections, may have a conical form, or may be undercut (for example made by milling that allows production of three dimensional geometries within the opening).
One exemplary application of the method and fastener according to the invention (the same as for known such methods and fasteners) is the replacement of a ruptured anterior cruciate ligament (ACL) in a human knee with a graft that is fastened, on the one hand, in an opening extending from the articular surface of the distal femur end and, on the other hand, in an opening extending from the tibia plateau, for example in a femoral blind opening and a tibial tunnel, wherein the tibial tunnel has a second mouth in the outer surface of the tibia below the tibia plateau. Therein the ruptured anterior cruciate ligament is usually replaced by a graft, such as, for example, a patellar tendon graft comprising two terminal bone blocks, a hamstring tendon graft (semitendinosus tendon, possibly combined with gracilis tendon), usually being folded and stitched in the end region, i.e. not comprising terminal bone blocks, or a quadriceps tendon graft, which is usually harvested with one terminal bone block. The named grafts are usually autografts but may also be donor grafts (allografts). Donor grafts may also be made of achilles tendons. It is further proposed to use synthetic ribbons and suitably treated tendon material of slaughtered animals (xenografts), such as pigs. The named autografts and allografts may furthermore be reinforced with synthetic material.
Further application fields of the method and fastener according to the invention are, for example, surgical procedures regarding the human foot or ankle, such as lateral ankle reconstruction, FDL tendon transfer (flexor digitorum longus), FHL tendon transfer (flexor hallucius longus), or flexor to tendon transfer (second toe); surgical procedures regarding the human hand such as ligament reconstruction tendon interposition, scapholunate ligament reconstruction, collateral ligament reconstruction, or UCL repair (ulnar collateral ligament) of the thumb (also known as “gamekeeper's thumb”); surgical procedures regarding the human elbow such as UCL repair (ulnar collateral ligament), or distal biceps tendon repair; or surgical procedures regarding the human shoulder such as proximal biceps tendon repair. A further example is the repair of torn or damaged cranial cruciate ligaments (CCL) in stifle joints in particular of dogs but also of other animals, such as cats. The CCL is the most commonly damaged stifle ligament in dogs and the named repair is carried out using nylon bands that are passed around the fabella bone in the back of the femur and are fixed in a bore provided in the front part of the tibia.